Andrew Rohrbaugh, Vice President, Strategic Solutions

As the Coronavirus (COVID-19) pandemic continues to impact clinical trials globally, we have seen a significant shift in focus to trial continuity – identifying ways to ensure that existing study participants are able to continue receiving investigational product, and maintain their participation in an ongoing clinical trial.

Distribution vendors are experiencing delays in shipment times as travel methods and borders are opened and closed. Delays include additional time required for COVID-19 screening at physical sites or hospitals before entering the facility to complete their delivery.  While most sites have been able to remain open globally due to their life-sustaining activities, some have experienced closures, and others are working through a reduction in staff.  Many study participants and patients are now unable to travel to sites. For those who can travel may be rescheduled for different days and appointment times.  Additionally, fear of contracting COVID-19 while traveling to, or at sites has resulted in increased anxiety for some, and early withdrawal from clinical trials for others.

While modern IRT systems provide robust drug supply functionality to ensure that the right drug is available for the right patient at the right site every time, the algorithms and logic behind this are based on pre-defined variables and assumptions.  Key among these are expectations that participants will be physically at sites for scheduled visits on the expected visit date, or within a pre-defined window around that date.  A limited amount of buffer stock is often allotted to account for unscheduled visits, and variances. However, with a COVID-19 induced “new normal,” the variance currently seen by clinical supply personnel strays significantly from the standard deviation.

An IRT system’s standard reports should include variations of an Unblinded Site Stock report, an Unblinded Depot Stock report, and Upcoming Visit report.  The first two allow clinical supplies users to review the current inventory at a site, and the remaining inventory at the depot supplying that site.  The Upcoming Visit report should allow those same users to see what visits are expected within a specified time period, and therefore what drug will be required for those visits, which is the same data used by the IRT’s resupply algorithm.  As alternative dispensing pathways are reviewed, these data can be used to determine the impact to site stock, as well as the need for changes to resupply settings, or manual orders.

If a trial was designed to dispense kits to participants at weekly visits, and it is determined that participants can instead skip visits when documented appropriately, the IRT can dispense multiple kits at a single visit in order to limit the number of at site visits that may be required for a participant to continue in the trial.  This may require an update to the IRT functionality. However, as a short-term solution, this can also be supported through a manual process by an IRT vendor.  If pivoting to dispensing multiple kits at each visit, this will likely require an increase in site stock, which will also deplete depot stock more quickly.  Reviewing the various reports and outputs from your IRT system, the full impact of such alternatives can be determined in order to align upon the optimal solution.

Direct-to-patient approaches have been discussed at most eClinical conferences for the past several years, with the recent refrain pushing sponsors to shift past the “pilot” phase of these study designs.  Regulations and acceptance of direct-to-patient models vary by country. However, several have encouraged the use of such approaches within guidance focused on the continuation of clinical trials during the COVID-19 pandemic.  If this is a direction your company is considering, I encourage you to reach out to your IRT partners to further assess feasibility.  If the distribution vendors with whom you are partnering have direct-to-patient experience, it may be possible be implemented rapidly once any necessary protocol revisions and appropriate documentation are in place. From an IRT perspective, there may be minimal, or even no system updates required to support such a change.  In cases where sites are hand delivering investigational product, or directly locating couriers to deliver drug to patients where continuous dosing is critical, the addition of a tracking number field, or delivery confirmation form to your IRT may sufficiently close the chain of custody loop near term.

Long term, we will likely see several changes to our daily lives as a result of the COVID-19 pandemic.  For those of us in the eClinical industry, this may be the impetus that drives the decentralization of clinical trials where possible, and wider adoption of direct-to-patient approaches.  With our current focus on trial continuity it is important to remember that sponsors and vendors are partners working towards a common goal of ensuring that investigational study drug continues to reach the patients and participants who need it most.